Abbott

JOB DESCRIPTION:

ABOUT ABBOTT

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

WORKING AT ABBOTT

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:

• Career development with an international company where you can grow the career you dream of.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

Primary Job Function:

Control the Quality Systems about Compliance at Abbott Healthcare Vietnam

Delegated person (from Site Quality Head) for releasing product and product quality decision

Core Job Responsibilities:

1. Join to establish and manage the quality system – compliance area.

2. Built and manage the document system.

3. CAPA/ Management of change, exception, CAPA.

4. Complaint, returned, recalled products.

5. Audit, Internal audit

6. Training, personnel management

7. Delegation from Site Quality Head

8. Delegation from similar manager role in Quality Unit (Site)

Position & Accountability:

1. Join to build the Quality policy and the Quality system of Site.

• Join in the deployment of compliance programs at site (Quality culture, Audit finding sharing, Quality watch, Inspection Readiness Program-IRP, IT Quality systems…)

2. Built and manage the document system.

• Review and approve the documents of the Quality System.
• In co-ordination with the QC Department, approve technical specifications, recalled products; control the complaint products; train about GMP; change control, exception, CAPA, records …
• GMP/ Supervise the management of the document system and GMP document.

3. Management of change, exception, CAPA.

• Review all change, exception related to QC, Microbiology, Regulatory affair, EHS. Review OOS related to the incoming material, semi-finished products, finished products, stability study and environment monitoring results and other OOS results (if any)
• Organize the investigation and identify the root cause.

4. Complaint, returned, recalled products.

• Join in the building of the monitoring system of the drug quality during distribution, complaint receiving and handling, returned product handling and recall product.
• Co-operate with the Medical department to handle complaint situations related to adverse event reports.

5. Audit, Internal audit

• Make a plan for the preparation of GMP approval and establish registration records to ask for GMP certification.
• Join in the welcome of the government inspection and external audit related with the quality system and GMP.
• Ensure the implementation of the annual internal audit

6. Participate the GMP training program when necessary.

• Manage, review the plan establishment and execution of the QA department.
• Is responsible for the annual evaluation of the sub-bordinate employees.
• Participate the GMP training program when necessary.
• Manage, review the plan establishment and execution of the QA department.
• Is responsible for the annual evaluation of the sub-bordinate employees.

7. Delegation from Site Quality Head

• Signature for Quality Head for product release and other documents as assigned by Quality Head.
• Designee of Quality Head to solve issues related to compliance and system not available at site.

8. Delegation from similar manager role in Quality Unit (site)

• Signature for QA Manager (Operation) for areas which are trained same as QA Manager (Operation).
• Signature for QC Manager for approval of sampling incoming raw materials in case the QC manager is not available at site.
• All these “signature for” must comply with Good document practices

Minimum Education:

• At least bachelor’s degree (Pharmaceutical), master in the quality system.
• Understanding the systematic process of WHO-GMP, PIC/S -GMP, EU-GMP, in the pharmaceutical industry.

Minimum Experience/Training Required:

• At least 2 years of experience at equivalent position, having experience of pharmaceutical company or manufacturer. At least 3 years of QA/ Production/ QC.
• Ability to use MS office
• Ability to use English
• Time management, organize working
• Demonstrated ability to build the trusting relationships with management and other business stakeholders
• Ability to initiate and drive organizational change in complex matrix environment, lead others through change, effectively manage resistance, and ensure organization engagement, influence and drive/ facilitate change across the organization
• Team work and project management skill, communication skills, enable people to result
• Leadership skills

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Operations Quality

DIVISION:

EPD Established Pharma

LOCATION:

Vietnam > Thuan An : Binh Duong Plant 1

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

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